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BI 690517 moderate hepatic impairment (Child-Pugh B) for Liver Disease
Phase 1
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 days
Awards & highlights
Study Summary
This trial tests how mild & moderate liver disease affects drug safety, how it's absorbed & how well it's tolerated.
Eligible Conditions
- Liver Disease
- Healthy Subjects
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Maximum measured concentration of the analyte in plasma (Cmax)
Secondary outcome measures
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Trial Design
3Treatment groups
Experimental Treatment
Group I: BI 690517 normal hepatic functionExperimental Treatment1 Intervention
control group
Group II: BI 690517 moderate hepatic impairment (Child-Pugh B)Experimental Treatment1 Intervention
Group III: BI 690517 mild hepatic impairment (Child-Pugh A)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 690517
2017
Completed Phase 2
~1040
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
IQVIA global CROUNKNOWN
Boehringer IngelheimLead Sponsor
2,515 Previous Clinical Trials
11,347,260 Total Patients Enrolled
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